Wound and mucosa antiseptics based on bispyridiniumalkanes are known. Bispyridiniumalkanes are active ingredients which are characterized by high efficacy coupled with low absorption on wounds. For example, EP 0 411 315 A1 discloses an aqueous antiseptic composition which comprises octenidine dihydrochloride and phenoxyethanol and/or phenoxy-propanol in a specific weight ratio. Octenidine dihydrochloride (referred to as octenidine below) is a quaternary ammonium compound, and specifically a bispyridiniumalkane, with the following structure:

The compositions according to DE 196 47 692 A1 comprise octenidine, C1- to C8-alkyl alcohol, nonionic and/or cationic surfactant and skin-compatible α-hydroxycarboxylic acid and are used as washing hand disinfectant.
Moreover, the product Octenisept® has been successfully sold for many years as mucosa and wound antiseptic.
Octenisept® consists inter alia of 0.1% by weight of octenidine dihydrochloride, 2% by weight of phenoxyethanol and cocamidopropylbetaine as amphoteric surfactant in aqueous solution.
EP 1 982 696 A1 discloses antiseptic gels based on a specific poloxamer. Poloxamers are nonionic surfactants and are prepared by copolymerizing propylene oxide with ethylene oxide. The gels comprise octenidine and/or polyhexanide as active ingredient and are characterized by an increase in the viscosity in the range from 20 to 30° C.
The aqueous antiseptic according to DE 102 05 883 A1 comprises octenidine and nonionic surfactant selected from alcohol polyalkoxylates, polysorbates and alkyl glycosides. It is free from alcohols and can be both rendered isotonic and also diluted with salt solutions to give isotonic solutions without resulting in precipitations. As explained in DE 102 05 883 A1, precipitations in an antiseptic that has been rendered isotonic are undesired because they lead to hypo- or hypertonic solutions or to a change in the active ingredient content.
The known wound and mucosa antiseptics are associated with disadvantages.
Antiseptics which necessarily require the presence of alcohols (for example aliphatic alcohols such as ethanol, propanol or butanol or aromatic alcohols such as benzyl alcohol, phenoxyethanol or phenoxypropanol) should be avoided on account of potential allergic reactions.
Antiseptics with a content of (cationic, anionic, nonionic and/or amphoteric) surfactant as secondary constituent likewise involve the risk of an allergy potential and can lead to severe undesired foaming for example in the case of ultrasound assisted wound treatment (UAW).
Moreover, compositions for wound and mucosa antisepsis should be able to be formulated isotonically, as is already described in DE 102 05 883 A1. Solutions isotonic to blood plasma contain dissolved particles in a concentration of 290 mOsmol/kg, e.g. 0.9% aqueous NaCl solution. The isotonicity of antiseptics is usually adjusted using inorganic salts, as are present in Ringer's solutions and NaCl solution. However, in the case of antiseptics which are rendered isotonic with the help of inorganic salts such as NaCl or Ringer's solution, there is always the risk of precipitations during storage, especially at a low temperature.
Ultimately, antiseptics are undesired which comprise large amounts of active ingredient and/or two or more active ingredients for satisfactory antimicrobial efficacy, or which comprise one or more secondary constituents since this is associated with the risk that the composition could not be used in patients who cannot tolerate just one of the active ingredients or secondary constituents. Consequently, antiseptics should only comprise the ingredients that are absolutely necessary for the application.
The object of the present invention was therefore to provide a composition for use as wound and mucosa antiseptic. The composition does not automatically require the presence of surfactant for good wettability, of alcohol for good efficacy and/or of inorganic salts for isotonicity. The compositions should be stable over a broad temperature range, i.e. not have a tendency towards separation of constituents (for example precipitations).